Adjuvant treatment with 5-fluorouracil and folinic acid with or without irinotecan in patients with Dukes B2 or C colon cancer.

Phase 3

Completed

• Conditions: colon cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12610000148077
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 870

Inclusion Criteria

Histologic proof of adenocarcinoma of the colon in who complete resection of the primary tumor has been performed with neither gross nor microscopic evidence of residual disease.
Dukes stage B or C disease.
The patient should be randomized into the study between 3 and 6 weeks postoperatively.
The patient must be willing and able to give informed consent according to the dispositions of the Helsinki convention and its Tokyo and Venice amendments.
The patient must be maintaining oral nutrition and must be ambulatory at least 50% of the day.

Exclusion Criteria

White Blood Cells (WBC) less than 3,500/mm3 or platelets < 100,000mm3
Any concurrent second malignant disease or any previous malignant tumor within the previous 3 years except superficial squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix.
Evidence of unresected distant or regional metastasis
Pregnant or lactating women
Ambulatory less than 50% of the day.
Current history of chronic diarrhea
Other serious illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)[3-year DFS rate (following randomisation). This outcome is assessed by physical examination, laboratory evaluation of hematology and biochemistry, computed tomography (CT), bone scan (if indicated), endoscopy at the end of the study]

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)[3-year survival rate (following randomisation). This outcome is assessed using clinical data records];Toxicity[1 month since the last administration of the drug. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc]